Candidate Mechanisms of Atherogenesis During the Post-prandial Period in the Obese Child/Adolescent
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in intermediate phenotypes of atherosclerosis from baseline to post-prandial phase
研究概览
简要总结
Childhood obesity is increasing at a fast pace, together with its complications. The aim of the present study is to assess several candidate triggering agents, mechanisms and intermediate phenotypes of atherosclerosis during the post-prandial phase in the obese insulin-resistant child/adolescent.
详细描述
Some of earlier outlines of the relationships between enlarged fat mass and insulin resistance have not been proven experimentally in man. For instance, most of the relationships shown in humans between cytokines and insulin sensitivity are correlational observations.
In the obese child, fatty liver is quite prevalent and is more closely associated than other fat depots to insulin resistance, dyslipidemia, high blood pressure and to high levels of inflammation markers. The entire picture, therefore, is consistent with an accelerated drive to atherosclerosis in the obese child/adolescent. Indeed, several reports have demonstrated that intermediate phenotypes of atherosclerosis can be detected in the obese child. Furthermore, the post-prandial phase is thought to play a role of its own in atherogenesis.
The investigators hypothesize that in the obese insulin-resistant child mechanisms of atherogenesis, such as hyperlipemia, oxidant stress and sub-inflammation, are activated in the post-prandial phase resulting in impairments of vascular function.
Parameters under study:
- Candidate triggering agents
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female
- •6 ≤ age ≤14 years
- •BMI ≥ 90th percentile for sex and age
- •Normal glucose tolerance
排除标准
- •Any overt disease other than obesity
- •Drugs known to interfere with vascular function for at least 2 weeks before study
- •Inflammatory diseases (assessed clinically and by routine blood tests)
- •1.8 < HOMA-IR < 2.5
结局指标
主要结局
Changes in intermediate phenotypes of atherosclerosis from baseline to post-prandial phase
时间窗: baseline and post-prandial phase
Intermediate Phenotypes of Atherosclerosis subject to dynamic changes: 1. Endothelial Function (flow-mediated vasodilation) (FMD) (assessed at baseline and at time= 180') 2. Arterial Stiffness (pulse-wave velocity) (PWV) (assessed at baseline and at times 60', 120', 180', 240', 300').
次要结局
未报告次要终点
研究者
Prof. C. Maffeis
Professor
Universita di Verona